Section 22-B10516. CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) SUMMARY

10516.1A 21 U.S.C. § 360(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.  The Department will accept summaries as well as amendments thereto until such time as the Department issues a determination of substantial equivalence. All 21 U.S.C. § 360(k) summaries shall contain the following information:

 

(a) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;

 

(b)The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;
 

(c)An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 21 U.S.C. § 360(k) premarket notification process;

 

(d)A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;

 

(e)A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in Paragraph (c) in this subsection, the 21 U.S.C. § 360(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled; and

 

(f) If the device has the same technological characteristics (for example, design, material, chemical composition, and energy source) as the predicate device identified in this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in this section.
 

10516.221 U.S.C. § 360(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment performance data shall contain the following information:

 

(a) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence;

 

(b) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and

 

(c)The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in § 10516.1(c) of this section.
 

10516.3The summary should be in a separate section of the submission, beginning on a new page and ending on a page not shared with any other section of the premarket notification submission, and should be clearly identified as a "21 U.S.C. § 360(k) summary."
 

10516.4The summary shall contain any other information that the Department reasonably deems necessary.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).